Investigating sleep and exercise effects on cognitive improvement in Parkinson's disease
Slow Wave Sleep As a Biomarker of Rehabilitation-induced Cognitive Improvement in Parkinson's Disease R01 HD100670
This study is testing whether different types of exercise can improve thinking skills in people with Parkinson's disease by looking at how their sleep affects their brain function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 45 Years to 100 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT04796506 on ClinicalTrials.gov |
What this trial studies
This study aims to explore how exercise rehabilitation impacts cognitive function in individuals with Parkinson's disease by evaluating slow wave sleep (SWS) as a potential biomarker for cognitive improvement. Participants will undergo progressive resistance training (PRT) for 12 weeks, and those who do not show an increase in SWS will switch to endurance training (ET). The study focuses on the relationship between SWS and cognitive performance, particularly executive function, to enhance rehabilitation outcomes tailored to individual responses. The ultimate goal is to maximize the efficacy of rehabilitation strategies for patients with Parkinson's disease.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 and older with a clinical diagnosis of idiopathic Parkinson's disease and specific cognitive assessment scores.
Not a fit: Patients who are regularly participating in an exercise program or have cardiovascular or pulmonary diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized rehabilitation strategies that significantly improve cognitive function in patients with Parkinson's disease.
How similar studies have performed: Previous studies have indicated a positive relationship between exercise, slow wave sleep, and cognitive function in Parkinson's disease, suggesting this approach has potential based on earlier findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion: * clinical diagnosis of idiopathic PD, based on the presence of bradykinesia as well as at least one of the following: rest tremor, rigidity, and/or postural instability (per United Kingdom PD Brain Bank Criteria) * Hoehn and Yahr stage 2-3 (performed at screening visit) * age ≥ 45 and * on stable medications for at least 4 weeks prior to study entry without expecting to change medications for the duration of the study. * Montreal Cognitive Assessment (MoCA) score ≥ 18 and \<26 (performed at screening visit) * No contraindications to an exercise program. Exclusion: * fails exercise readiness evaluation at screening visit * regular participation in an exercise program * cardiovascular or pulmonary disease, including uncontrolled hypertension, congestive heart failure, unstable coronary artery disease, serious arrhythmia, stroke within the past year, or chronic obstructive pulmonary disease (COPD) * shift workers * signs indicative of atypical Parkinsonism (cerebellar signs, supranuclear gaze palsy, apraxia, prominent autonomic failure, or other cortical signs) * secondary Parkinsonism (neuroleptic treatment at time of onset of Parkinsonism or at time of study entry, history of multiple strokes with stepwise progression of Parkinsonism, or history of multiple head injuries) * inability to walk without assistance * deep brain stimulation (DBS) * known narcolepsy * untreated sleep apnea * any condition that, in the opinion of the investigator, will preclude the participant from successfully or safely completing study procedures.
Where this trial is running
Aurora, Colorado
- University of Colorado, Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Amy Amara, MD, PhD — University of Colorado, Denver
- Study coordinator: Amy W Amara, MD, PhD
- Email: amy.amara@cuanschutz.edu
- Phone: 303.724.2194
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.